Comparative Evaluation and Measure of Accuracy of ELISAs, CLIAs, and ECLIAs for the Detection of HIV Infection among Blood Donors in China
Table 3
The performance of serology kits for HIV screening§.
Blood screening laboratories
HIV serology kits
Sensitivity n = 136 (%), 95% CI
Specificity n = 893 (%), 95% CI
Concordance rate||n = 1029 (%), 95% CI
PPV, 95% CI
NPV, 95% CI
Kappa (κ)
BJ
Wantai
134 (98.5%), 96.5%–100.5%
859 (96.2%)††, 95.0%–97.4%
993 (96.5%)††, 95.4%–97.6%
79.8%††, 73.7%–85.8%
99.8%, 99.4%–100.1%
0.861
HN
Wantai
131 (96.3%)†, 93.1%–99.5%
839 (94.0%)††, 92.5%–95.5%
970 (94.3%)††, 92.9%–95.7%
70.8%††, 64.3%–77.3%
99.4%†, 98.9%–99.9%
0.783
Wantai§
134 (98.5%), 96.5%–100.5%
861(96.4%)††, 95.2%–97.6%
995 (96.7%)††, 95.6%–97.8%
80.7%††, 74.8%–86.7%
99.8%, 99.4%–100.1%
0.868
YN
KHB
134 (98.5%), 96.5%–100.5%
872 (97.6%)†, 96.6%–98.6%
1006 (97.8%)††, 96.9%–98.7%
86.5%†, 81.1%–91.8%
99.8%, 99.5%–100.1%
0.908
JN
KHB
131 (96.3%)†, 93.1%–99.5%
868 (97.2%)††, 96.1%–98.3%
999 (97.1%)††, 96.1%–98.1%
84.0%††, 78.2%–89.7%
99.4%†, 98.9%–99.9%
0.880
LN
KHB
129 (94.9%)††, 91.2%–98.6%
843 (94.4%)††, 92.9%–95.9%
972 (94.5%)††, 95.4%–97.6%
72.1%††, 65.5%–78.6%
99.2%††, 98.6%–99.8%
0.787
KHB§
134 (98.5%), 96.5%–100.5%
873 (97.8%)†, 96.8%–98.8%
1007 (97.9%)†, 97.0%–98.8%
87.0%†, 81.7%–92.3%
99.8%, 99.5%–100.1%
0.912
SD
InTec
133 (97.8%), 95.3%–100.3%
879 (98.4%), 97.6%–99.2%
1012 (98.3%), 97.5%–99.1%
90.5%, 85.8%–95.2%
99.7%, 99.3%–100.0%
0.930
JS
InTec
133 (97.8%), 95.3%–100.3%
880 (98.5%), 97.7%–99.3%
1013 (98.4%), 97.6%–99.2%
91.1%, 86.5%–95.7%
99.7%, 99.3%–100.0%
0.934
HLJ
InTec
133 (97.8%), 95.3%–100.3%
875 (98.0%)†, 97.1%–98.9%
1008 (98.0%)†, 97.1%–98.9%
88.1%, 82.9%–93.2%
99.7%, 99.3%–100.0%
0.915
LN
InTec
132 (97.1%)†, 94.3%–99.9%
872 (97.6%)†, 96.6%–98.6%
1004 (97.6%)††, 96.7%–98.5%
86.3%†, 80.8%–91.7%
99.5%, 99.1%–100.0%
0.899
CQ
InTec
133 (97.8%), 95.3%–100.3%
876 (98.1%), 97.2%–99.0%
1009 (98.1%)†, 97.3%–98.9%
88.7%, 83.6%–93.7%
99.7%, 99.3%–100.0%
0.919
InTec§
133 (97.8%), 95.3%–100.3%
881 (98.7%), 98.0%–99.4%
1014 (98.5%), 97.8%–99.2%
91.7%, 87.3%–96.2%
99.7%, 99.3%–100.0%
0.938
HZ
Livzon
133 (97.8%), 95.3%–100.3%
875 (98.0%)†, 97.1%–98.9%
1008 (98.0%)†, 97.1%–98.9%
88.1%, 82.9%–93.2%
99.7%, 99.3%–100.0%
0.915
ZH
Livzon
133 (97.8%), 95.3%–100.3%
873 (97.8%)†, 96.8%–98.8%
1006 (97.8%)††, 96.9%–98.7%
86.9%†, 81.6%–92.2%
99.7%, 99.3%–100.0%
0.907
Livzon§
133 (97.8%), 95.3%–100.3%
876 (98.1%), 97.2%–99.0%
1009 (98.1%)†, 97.3%–98.9%
88.7%, 83.6%–93.7%
99.7%, 99.3%–100.0%
0.919
SD
Bio-Rad (4th)
136 (100%), 100.0%–100.0%
795 (89.0%)††, 87.0%–91.0%
931 (90.5%)††, 88.7%–92.3%
58.1%††, 51.8%–64.4%
100%, 100.0%–100.0%
0.682
SZ
Bio-Rad (4th)
136 (100%), 100.0%–100.0%
795 (89.0%)††, 87.0%–91.0%
931 (90.5%)††, 88.7%–92.3%
58.1%††, 51.8%–64.4%
100%, 100.0%–100.0%
0.682
BJ
Bio-Rad (4th)
136 (100%), 100.0%–100.0%
798 (89.4%)††, 87.4%–91.4%
934 (90.8%)††, 89.0%–92.6%
58.9%††, 52.6%–65.2%
100%, 100.0%–100.0%
0.689
HLJ
Bio-Rad (4th)
136 (100%), 100.0%–100.0%
797 (89.2%)††, 87.2%–91.2%
933 (90.7%)††, 88.9%–92.5%
58.6%††, 52.3%–64.9%
100%, 100.0%–100.0%
0.687
Bio-Rad (4th)§
136 (100%), 100.0%–100.0%
812 (90.9%)††, 89.0%–92.8%
948 (92.1%)††, 90.5%–93.7%
62.7%††, 56.3%–69.1%
100%, 100.0%–100.0%
0.726
JL
Wantai (4th)
135 (99.3%), 97.9.0%–100.7%
843 (94.4%)††, 92.9%–95.9%
978 (95.0%)††, 93.7%–96.3%
73.0%††, 66.6%–79.3%
99.9%, 99.7%–100.1%
0.813
JS
Wantai (4th)
135 (99.3%), 97.9.0%–100.7%
863 (96.6%)††, 95.4%–97.8%
998 (97.0%)††, 96.0%–98.0%
81.8%††, 76.0%–87.7%
99.9%, 99.7%–100.1%
0.88
TJ
Wantai (4th)
133 (97.8%), 95.3%–100.3%
853 (95.5%)††, 94.1%–96.9%
986 (95.8%)††, 94.6%–97.0%
76.9%††, 70.6%–83.1%
99.6%, 99.3%–100.0%
0.837
HB
Wantai (4th)
134 (98.5%), 96.5%–100.5%
854 (95.6%)††, 94.3%–96.9%
988 (96.0%)††, 94.8%–97.2%
77.5%††, 71.3%–83.7%
99.8%, 99.4%–100.1%
0.844
Wantai (4th)§
135 (99.3%), 97.9.0%–100.7%
863 (96.6%)††, 95.4%–97.8%
998 (97.0%)††, 96.0%–98.0%
81.8%††, 76.0%–87.7%
99.9%, 99.7%–100.1%
0.880
TZ
Murex (4th)
135 (99.3%), 97.9.0%–100.7%
833 (93.3%)††, 91.7%–94.9%
968 (94.1%)††, 92.7%–95.5%
69.2%††, 62.8%–75.7%
99.9%, 99.6%–100.1%
0.782
CZ
Murex (4th)
135 (99.3%), 97.9.0%–100.7%
834 (93.4%)††, 91.8%–95.0%
969 (94.2%)††, 92.8%–95.6%
69.6%††, 63.1%–76.0%
99.9%, 99.6%–100.1%
0.785
HB
Murex (4th)
135 (99.3%), 97.9.0%–100.7%
849 (95.1%)††, 93.7%–96.5%
984 (95.6%)††, 94.4%–96.8%
75.4%††, 69.1%–81.7%
99.9%, 99.7%–100.1%
0.832
Murex (4th)§
135 (99.3%), 97.9.0%–100.7%
842 (94.3%)††, 92.8%–95.8%
977 (94.9%)††, 93.6%–96.2%
72.6%††, 66.2%–79.0%
99.9%, 99.7%–100.1%
0.809
ZH
Livzon (4th)
135 (99.3%), 97.9.0%–100.7%
869 (97.3%)††, 96.2%–98.4%
1004 (97.6%)††, 96.7%–98.5%
84.90%††, 79.4%–90.4%
99.90%, 99.7%–100.1%
0.901
NCCL
ECLIA
136 (100%), 100.0%–100.0%
884 (99.0%), 98.4%–99.6%
1020 (99.1%), 98.5%–99.7%
93.8%, 89.9%–97.7%
100%, 100.0%–100.0%
0.963
NCCL
CLIA
136 (100%), 100.0%–100.0%
885 (99.1%), 98.5%–99.7%
1021 (99.2%), 98.7%–99.7%
94.4%, 90.7%–98.2%
100%, 100.0%–100.0%
0.967
§The final result of each ELISA among 1029 blood donations was determined by more than half results of different blood centers using the same ELISA and S/CO if the number of reactive and nonreactive results was equal. ||The proportion of true results among samples screened by HIV serology kits. ,,†,††, ELISA, and ECLIA: the values (∗) were compared with ECLIA (Roche Elecsys HIV combi PT); ELISA and CLIA: the values (†) were compared with CLIA (Abbott ARCHITECT HIV Ag/Ab Combo).
